Ulcerative ColitisPhase 1SCOUTNCT05084261
An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)
A Phase 1 study testing BT051 200 mg, BT051 800 mg and BT051 3200 mg in people with Ulcerative Colitis, run by Adiso Therapeutics at 6 sites in 4 countries.
Trial summary
This is a randomised, double-blind, placebo-controlled study to assess the safety and tolerability of multiple ascending doses of BT051 in subjects with moderately to severely active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- BT051 200 mg, BT051 800 mg and BT051 3200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 30 Nov 2021to 30 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written documentation of informed consent to participate in the study.
- Male or female aged 18 to 75 years.
- Subjects with a confirmed diagnosis of UC of at least 3 months' disease duration prior to Screening (diagnosis established by endoscopy and histology).
- Moderately to severely active UC, defined as a Mayo Score ≥6 points with a rectal bleeding subscore ≥1 point, a stool frequency subscore ≥1 point, and moderate to severe disease on endoscopy (Mayo endoscopic subscore [MES] ≥2 points).
- Subjects treated with stable doses (>4 weeks) of the following UC treatments prior to randomization: 6-mercaptopurine, azathioprine, sulfasalazine or 5-aminosalicylic acid. Subjects will need to maintain stable doses of these drugs for at least 4 weeks during study treatment and an additional 7 days of follow-up.
- Subjects treated with oral corticosteroids will be eligible if the dose is ≤20 mg/day prednisone (≤9 mg/day budesonide) or equivalent. The corticosteroid therapy will have to be stable for at least 2 weeks prior to the Screening sigmoidoscopy, throughout study treatment and an additional 7 days of follow-up.
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- Colonoscopy within the past 1 year to exclude adenomas, dysplasia, and colon cancer for subjects with 1/3 of colon involved and 8 years of disease; those without a colonoscopy in the past year may use the Screening colonoscopy to confirm eligibility.
- Female subjects must be surgically sterile, postmenopausal (i.e., no menses for at least 2 years or documented by follicle stimulating hormone), or if of child-bearing potential must have a negative pregnancy test and must be willing to use a highly effective form of contraceptive through 30 days after the last dose of study drug. The following are considered highly effective contraceptives: combined and progestogen-only hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable, implantable), intrauterine device/hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or abstinence. Abstinence should only be used as a contraceptive method if it is in line with the subject's usual and preferred lifestyle. Periodic abstinence (calendar, symptothermal, post ovulation methods) is not an acceptable method of contraception.
- Male subjects must be surgically sterile, abstinent, agree to use an appropriate contraception method (i.e., condom), or have a female sexual partner who is surgically sterile, postmenopausal, or using a highly effective form of contraceptive as noted above through 30 days after the last dose of study drug. Abstinence should only be used as a contraceptive method if it is in line with the subject's usual and preferred lifestyle.
- General Exclusion Criteria
- Any clinically significant disease: renal, hepatic, neurological, cardiovascular, pulmonary, endocrinology, psychiatric, hematologic, urologic, or other acute or chronic disease that in the opinion of the Investigator would not make the subject a suitable candidate for this study.
- Subjects with planned hospitalization or surgery during the course of the study.
- Female subjects who have a positive pregnancy test, are breast feeding, or intend to become pregnant during the course of the study. Male subjects who intend female partner pregnancy during the course of the study.
- Known hypersensitivity to any of the components of BT051 drug product including cyclosporine A and polyethylene glycol.
- Relative to upper limit of normal (ULN):
- Serum bilirubin >1.5×
- Serum creatinine >1.5×
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >2.0×
- International normalized ratio (INR) >1.5
- Hemoglobin <8 g/dL
- Cell counts (/μL):
- Platelets <100,000 or >800,000
- White blood cells <3500
- Absolute neutrophil count <1500
- Systemic antibiotic, antiviral, or anti-fungal therapy within the 2 weeks prior to Screening.
- Live or live-attenuated virus vaccination within the 2 weeks prior to randomization or planned vaccination during the study. Vaccination against SARS-CoV-2 using licensed vaccines will be permitted.
- History of cancer within the past 5 years (permitted exceptions: subjects with excised basal cell carcinoma, squamous cell carcinoma of the skin, and cervical carcinoma in situ who have been treated and cured).
- Drug, chemical, or alcohol dependency within the past 2 years as determined by the investigator.
- A positive diagnostic tuberculosis (TB) test at screening (defined as a positive QuantiFERON test). In cases where the QuantiFERON test is indeterminate, the subject may have the test repeated once and if their second test is negative, they will be eligible. In the event a second test is also indeterminate, or QuantiFERON is unavailable, the investigator has the option to perform a purified protein derivative (PPD) skin test (PPD skin test may not be used if subject was previously vaccinated with bacille Calmette-Guerin [BCG]). If the PPD reaction is <5 mm, then the subject is eligible. If the reaction is ≥5 mm, or PPD testing is not done, the subject is not eligible.
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at Screening. If the initial test is positive but reflex testing (performed on the same sample) is negative, then the subject is eligible.
- Inability to comply with study requirements.
- Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
- Subjects enrolled in another clinical trial assessing an investigational drug (or medical device) within 30 days or 5 half-lives (whichever is longer) prior to Screening (or within 60 days prior to Screening if investigational drug was a biologic).
- Gastrointestinal Exclusion Criteria
- Fulminant colitis, toxic megacolon, or severe ulcerative colitis as defined: currently hospitalized for UC, fever, persistent tachycardia, or hemoglobin <8 g/dL.
- Subject has any of the following conditions: primary sclerosing cholangitis, Crohn's disease, diverticulitis, bowel fistulas, history of colitis-associated colonic dysplasia, or active peptic ulcer disease.
- Ulcerative colitis diagnosis limited to isolated proctitis.
- Current ileostomy or colostomy.
- Proctocolectomy or total colectomy.
- Known symptomatic colonic stricture.
- Current stool cultures or tests positive for an enteric infection, including parasitic infection and Clostridioides difficile toxin.
- Short bowel syndrome requiring enteral or parenteral nutrition supplementation or total parenteral nutrition.
- Diagnosis of microscopic or indeterminate colitis.
- Bowel surgery within 3 months prior to randomization, or likely to need bowel surgery in next 4 months.
- Any known history of listeria infection.
- A current bacterial, parasitic, fungal, or viral infection (except blastocystis hominis).
- Prior Medication Exclusion Criteria
- Prior biologic therapy:
- Adalimumab, infliximab, golimumab, etanercept, ustekinumab or certolizumab within the 60 days prior to Day 1.
- Vedolizumab within 120 days prior to Day 1.
- Topical mesalamine or corticosteroid (i.e., enemas or suppositories) within the 14 days prior to Day 1.
- Tofacitinib within the 30 days prior to Day 1.
- Subjects treated with parenteral corticosteroids or calcineurin inhibitors cyclosporine, or tacrolimus within 4 weeks prior to randomization.
- Regular use of other medications not mentioned above, including over-the-counter medications or supplements, that may impact the subject's UC or intestinal motility as determined by the investigator.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States2 sites
I.H.S. Health, LLC
Kissimmee, Florida, 34741
Inland Empire Clinical Trials, LLC
Rialto, California, 92377
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled, Multiple-Ascending-Dose Investigation of the Oral Anti-Inflammatory Agent BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)
This is a randomised, double-blind, placebo-controlled study to assess the safety and tolerability of multiple ascending doses of BT051 in subjects with moderately to severely active ulcerative colitis. Subjects will be randomised using a 3 active:1 placebo ratio to 3 ascending dose cohorts of 8 subjects and will be dosed daily for 28 days. The 3 initial dose levels will be 200 mg, 800 mg and 3200 mg per day. Progression to the next cohort will be based on the safety and tolerability of the previous cohort.
Read the detailed description
This is a randomized, placebo-controlled, multiple-ascending-dose (MAD) study enrolling subjects with moderately to severely active UC. Subjects with prior exposure to biologic or JAK inhibitors will be limited to 30% of the total subject population; those who have failed 2 or more biologic therapies (i.e., biologic and JAK inhibitor, 2 biologics in the same class, or 2 biologics from different classes) will be limited to 20% of the total subject population. Subjects will be randomized to one of 3 doses of oral BT051 (200 mg, 800 mg, or 3200 mg) or placebo, in ascending dose groups based on the safety and tolerability of the previous cohort. Safety and tolerability will be assessed by a Safety Review Committee (SRC) after all subjects in each cohort have completed at least 14 days of treatment, before proceeding to the next higher dose cohort. The SRC may recommend that the next cohort proceed with a higher dose as planned, or the SRC may recommend additional subjects be dosed at the current, previous, or lower dose of study drug.
Each planned dose escalation cohort (Cohorts 1-3) will include 8 subjects randomized 3:1 to receive active drug or placebo. Starting with the lowest dose, each cohort of subjects will receive once daily oral BT051 or placebo for a period of 28 days. Follow-up visits will be performed at 7 and 30 days after the last dose.
- Conditions
- Ulcerative Colitis
- Being tested
- BT051 200 mg, BT051 800 mg, BT051 3200 mg, Matching Placebo
- Keywords
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT051 200 mgDrug
Also called ADS051
Oral BT051 200 mg once daily for 28 days.
BT051 800 mgDrug
Also called ADS051
Oral BT051 800 mg once daily for 28 days.
BT051 3200 mgDrug
Also called ADS051
Oral BT051 3200 mg once daily for 28 days.
Matching PlaceboDrug
Placebo Matching BT051
| Study group | Role | What they receive |
|---|---|---|
| BT051 200 mg | Experimental | Participants will receive oral BT051 200 mg once daily for 28 days. Receives: Drug: BT051 200 mg |
| BT051 800 mg | Experimental | Participants will receive oral BT051 800 mg once daily for 28 days. Receives: Drug: BT051 800 mg |
| BT051 3200 mg | Experimental | Participants will receive oral BT051 3200 mg once daily for 28 days. Receives: Drug: BT051 3200 mg |
| Placebo | Placebo comparator | Participants will receive oral Placebo to match BT051 once daily for 28 days. Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of BT051 based on the difference of proportions between treatment groups of subjects experiencing treatment-emergent adverse events (TEAEs)
Proportion of subjects experiencing a TEAE will be summarized using the MedDRA system organ class and preferred term
Measured: Baseline to Day 58
Evaluate the safety and tolerability of BT051 based on the difference of proportions between treatment groups of subjects observed with a change from baseline in physical examinations, clinical laboratory tests, vital signs, and electrocardiograms (ECG)
Proportion of subjects with a change from baseline from normal to abnormal in physical examinations, clinical laboratory tests, vital signs, and ECGs will be summarized
Measured: Baseline to Day 58
Secondary outcomes (13)
Clinical response defined as a decrease in complete Mayo Score ≥3 points and ≥30% from baseline with a concomitant decrease in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point
Proportion of subjects who achieve clinical response defined as a decrease in complete Mayo Score ≥3 points and ≥30% from baseline with a concomitant decrease in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point at Day 28
Measured: Baseline to Day 28
Clinical response defined as a decrease in complete Mayo Score ≥2 points and ≥30% from baseline with a concomitant decrease in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1
Proportion of subjects who achieve clinical response defined as a decrease in complete Mayo Score ≥2 points and ≥30% from baseline with a concomitant decrease in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point at Day 28
Measured: Baseline to Day 28
Remission defined as a complete Mayo Score ≤2 points with no subscore >1 point at Day 28
Proportion of subjects in clinical remission defined as a complete Mayo Score ≤2 points with no subscore >1 point at Day 28
Measured: Baseline to Day 28
Remission defined as a partial Mayo Score ≤2 points with no subscore >1 point at Days 14 and 28
Proportion of subjects in clinical remission defined as a partial Mayo Score ≤2 points with no subscore >1 point at Day 14 and Day 28
Measured: Baseline to Days 14 and 28
Remission according to the adapted Mayo Score without the physician's global assessment, defined as a stool frequency subscore ≤1 point, rectal bleeding subscore of 0, and endoscopic subscore ≤1 point
Proportion of subjects in clinical remission according to the adapted Mayo Score without the physician's global assessment, defined as a stool frequency subscore ≤1 point, rectal bleeding subscore of 0, and endoscopic subscore ≤1 point
Measured: Baseline to Day 28
Change in Mayo endoscopic, stool frequency, and rectal bleeding subscores.
Proportion of subjects with a change in Mayo endoscopic, stool frequency, and rectal bleeding subscores from baseline to Day 28
Measured: Baseline to Day 28
Change in stool frequency and rectal bleeding Mayo subscores
Proportion of subjects with a change in stool frequency and rectal bleeding Mayo subscores from baseline to Day 14
Measured: Baseline to Day 14
Endoscopic remission defined as an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of 0
Proportion of subjects who achieve endoscopic remission defined as an UCEIS score of 0 at Day 28
Measured: Day 28
Endoscopic response defined as a decrease in UCEIS ≥2 points
Proportion of subjects who achieve endoscopic response defined as a decrease in UCEIS ≥2 points at Day 28.
Measured: Day 28
Histologic remission defined as Geboes Score ≤2B.0 or Nancy Index = 0
Proportion of subjects who achieve histologic remission (defined as Geboes Score ≤2B.0 or Nancy Index = 0) at Day 28
Measured: Day 28
Change in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score
Difference between treatment groups of mean change in UCEIS score from baseline to Day 28.
The UCEIS consists of the following 3 descriptors and is calculated as a simple sum: erosions and ulcers (scored 0-3), bleeding (scored 0-3) and vascular pattern (scored 0-2). Calculated scores range from 0 to 8 with higher scores indicating more severe disease.
Measured: Baseline to Day 28
Change in Robarts histopathology index (RHI) score
Difference between treatment groups of mean change in Robarts histopathology index (RHI) score from baseline to Day 28.
The RHI score ranges from 0 (no disease activity) to 33 (severe disease activity) based on the evaluation of 4 main parameters: chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in the epithelium, and erosion and ulceration.
Measured: Baseline to Day 28
Change in UC-100 score
Difference between treatment groups of mean change in UC-100 score from baseline to Day 28.
The UC-100 is a composite disease activity index consisting of clinical, endoscopic, and histological findings. The UC-100 will be calculated by adding the weighted Mayo stool frequency and endoscopy subscores, and RHI score as follows:
UC-100 Score = 1 + (16 × stool frequency) + (6 × MES) + (RHI score)
The total UC-100 score ranges from 1 to 100, with higher scores representing more severe disease activity.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start30 Nov 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiso Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renu Gupta, MD, Study director, Adiso Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084261
- Sponsor's protocol ID
- BT051-1-002
- Acronym
- SCOUT
- Status last verified
- Feb 2024
- First submitted
- 20 Sep 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Allegretti JR, Cheifetz AS, Dulai PS, Stevens AC, Chapas-Reed J, Chesnel L, Dixit B, Farquhar R, Ghahramani P, Miller BW, Murphy CK, Quintas M, Tanase R, Telia T, Wozniak-Stolarska B, Gupta R. Safety, Pharmacokinetics, and Clinical Efficacy of ADS051, a Neutrophil Modulator, in Ulcerative Colitis: Results of a Randomized Phase 1b Trial. Am J Gastroenterol. 2024 Dec 31;120(7):1624-1635. doi: 10.14309/ajg.0000000000003269.
PubMed 39787364
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled, Multiple-Ascending-Dose Investigation of the Oral Anti-Inflammatory Agent BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)
- ClinicalTrials.gov ID
- NCT05084261
- Acronym / sponsor ID
- SCOUT / BT051-1-002
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Adiso TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised, double-blind, placebo-controlled study to assess the safety and tolerability of multiple ascending doses of BT051 in subjects with moderately to severely active ulcerative colitis. Subjects will be randomised using a 3 active:1 placebo ratio to 3 ascending dose cohorts of 8 subjects and will be dosed daily for 28 days. The 3 initial dose levels will be 200 mg, 800 mg and 3200 mg per day. Progression to the next cohort will be based on the safety and tolerability of the previous cohort.
Detailed description
This is a randomized, placebo-controlled, multiple-ascending-dose (MAD) study enrolling subjects with moderately to severely active UC. Subjects with prior exposure to biologic or JAK inhibitors will be limited to 30% of the total subject population; those who have failed 2 or more biologic therapies (i.e., biologic and JAK inhibitor, 2 biologics in the same class, or 2 biologics from different classes) will be limited to 20% of the total subject population. Subjects will be randomized to one of 3 doses of oral BT051 (200 mg, 800 mg, or 3200 mg) or placebo, in ascending dose groups based on the safety and tolerability of the previous cohort. Safety and tolerability will be assessed by a Safety Review Committee (SRC) after all subjects in each cohort have completed at least 14 days of treatment, before proceeding to the next higher dose cohort. The SRC may recommend that the next cohort proceed with a higher dose as planned, or the SRC may recommend additional subjects be dosed at the current, previous, or lower dose of study drug.
Each planned dose escalation cohort (Cohorts 1-3) will include 8 subjects randomized 3:1 to receive active drug or placebo. Starting with the lowest dose, each cohort of subjects will receive once daily oral BT051 or placebo for a period of 28 days. Follow-up visits will be performed at 7 and 30 days after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BT051 200 mg | Experimental | Drug: BT051 200 mgParticipants will receive oral BT051 200 mg once daily for 28 days. |
| BT051 800 mg | Experimental | Drug: BT051 800 mgParticipants will receive oral BT051 800 mg once daily for 28 days. |
| BT051 3200 mg | Experimental | Drug: BT051 3200 mgParticipants will receive oral BT051 3200 mg once daily for 28 days. |
| Placebo | Placebo comparator | Drug: Matching PlaceboParticipants will receive oral Placebo to match BT051 once daily for 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (54 listed)
- Provide written documentation of informed consent to participate in the study.
- Male or female aged 18 to 75 years.
- Subjects with a confirmed diagnosis of UC of at least 3 months' disease duration prior to Screening (diagnosis established by endoscopy and histology).
- Moderately to severely active UC, defined as a Mayo Score ≥6 points with a rectal bleeding subscore ≥1 point, a stool frequency subscore ≥1 point, and moderate to severe disease on endoscopy (Mayo endoscopic subscore [MES] ≥2 points).
- Subjects treated with stable doses (>4 weeks) of the following UC treatments prior to randomization: 6-mercaptopurine, azathioprine, sulfasalazine or 5-aminosalicylic acid. Subjects will need to maintain stable doses of these drugs for at least 4 weeks during study treatment and an additional 7 days of follow-up.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BT051 200 mgAlso: ADS051Oral BT051 200 mg once daily for 28 days. | Drug | BT051 200 mg |
| BT051 800 mgAlso: ADS051Oral BT051 800 mg once daily for 28 days. | Drug | BT051 800 mg |
| BT051 3200 mgAlso: ADS051Oral BT051 3200 mg once daily for 28 days. | Drug | BT051 3200 mg |
| Matching PlaceboPlacebo Matching BT051 | Drug | Placebo |
Primary outcome
Evaluate the safety and tolerability of BT051 based on the difference of proportions between treatment groups of subjects experiencing treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Day 58
Proportion of subjects experiencing a TEAE will be summarized using the MedDRA system organ class and preferred term
Evaluate the safety and tolerability of BT051 based on the difference of proportions between treatment groups of subjects observed with a change from baseline in physical examinations, clinical laboratory tests, vital signs, and electrocardiograms (ECG)
Time frame: Baseline to Day 58
Proportion of subjects with a change from baseline from normal to abnormal in physical examinations, clinical laboratory tests, vital signs, and ECGs will be summarized
13 secondary outcomes
Clinical response defined as a decrease in complete Mayo Score ≥3 points and ≥30% from baseline with a concomitant decrease in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point
Time frame: Baseline to Day 28
Clinical response defined as a decrease in complete Mayo Score ≥2 points and ≥30% from baseline with a concomitant decrease in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1
Time frame: Baseline to Day 28
Remission defined as a complete Mayo Score ≤2 points with no subscore >1 point at Day 28
Time frame: Baseline to Day 28
Remission defined as a partial Mayo Score ≤2 points with no subscore >1 point at Days 14 and 28
Time frame: Baseline to Days 14 and 28
Remission according to the adapted Mayo Score without the physician's global assessment, defined as a stool frequency subscore ≤1 point, rectal bleeding subscore of 0, and endoscopic subscore ≤1 point
Time frame: Baseline to Day 28
Change in Mayo endoscopic, stool frequency, and rectal bleeding subscores.
Time frame: Baseline to Day 28
Change in stool frequency and rectal bleeding Mayo subscores
Time frame: Baseline to Day 14
Endoscopic remission defined as an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of 0
Time frame: Day 28
Endoscopic response defined as a decrease in UCEIS ≥2 points
Time frame: Day 28
Histologic remission defined as Geboes Score ≤2B.0 or Nancy Index = 0
Time frame: Day 28
Change in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score
Time frame: Baseline to Day 28
Change in Robarts histopathology index (RHI) score
Time frame: Baseline to Day 28
Change in UC-100 score
Time frame: Baseline to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 39787364Allegretti JR, Cheifetz AS, Dulai PS, Stevens AC, Chapas-Reed J, Chesnel L, Dixit B, Farquhar R, Ghahramani P, Miller BW, Murphy CK, Quintas M, Tanase R, Telia T, Wozniak-Stolarska B, Gupta R. Safety, Pharmacokinetics, and Clinical Efficacy of ADS051, a Neutrophil Modulator, in Ulcerative Colitis: Results of a Randomized Phase 1b Trial. Am J Gastroenterol. 2024 Dec 31;120(7):1624-1635. doi: 10.14309/ajg.0000000000003269.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renu Gupta, MD study director
Adiso Therapeutics, Inc.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BT051 200 mg, BT051 800 mg and BT051 3200 mg in people with Ulcerative Colitis, run by Adiso Therapeutics at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 54 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Poland, Georgia, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of BT051 based on the difference of proportions between treatment groups of subjects experiencing treatment-emergent adverse events (TEAEs) (time frame: Baseline to Day 58). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05084261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.